XerostomiaNCT03005041
Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
A study testing Biotene mouthwash and Bottled mineral water in people with Xerostomia, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia
- What is being tested?
- Biotene mouthwash and Bottled mineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2016to 19 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18 - 84 years inclusive
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
- Participant reports having a feeling of a dry mouth according to the Dry Mouth Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1). Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the Screening Visit (Visit 1).
- Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the Screening Visit (Visit 1).
- Understands and is willing, able and likely to comply with all study procedures and restrictions
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or have a positive urine pregnancy test at the Screening Visit
- Women who are breast-feeding
- Participant is currently undergoing radiotherapy and/or chemotherapy treatment
- Any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. Alzheimer's Disease
- Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
- Evidence of gross intra-oral neglect or need for extensive dental therapy
Show all 14Show fewer
- Denture wearer (complete dentures)
- Participant not on stable doses of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- An employee of the sponsor or the clinical study team or members of their immediate family. Students and employees of the Tufts University School of Dental Medicine not associated with the clinical trials team are eligible to participate. Students and employees will not be specifically targeted for enrollment
- Non-English speaking Participants will not be enrolled in the study. Participants must be able to read and write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Boston, Massachusetts, 02111
About this study
Official title: A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
- Conditions
- Xerostomia
- Being tested
- Biotene mouthwash, Bottled mineral water
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotene mouthwashOther
Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
Bottled mineral waterOther
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Test Product 1 | Experimental | Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds. Receives: Other: Biotene mouthwash |
| Test Product 2 | Other | Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water. Receives: Other: Bottled mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..
Measured: Within 2 minutes post product use
Secondary outcomes (3)
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth \& how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.
Measured: Within 2 minutes post product use
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)
Measured: Within 30 ± 5 minutes post product use
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.
Measured: Within 5 minutes post product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start31 Aug 2016
- Primary completion19 Oct 2016
- Study completion19 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005041
- Sponsor's protocol ID
- 205067
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2016
- Last updated
- 19 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
- ClinicalTrials.gov ID
- NCT03005041
- Acronym / sponsor ID
- 205067
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product 1 | Experimental | Other: Biotene mouthwashParticipants will rinse their mouth with 15 mL of the product swishing for 30 seconds. |
| Test Product 2 | Other | Other: Bottled mineral waterParticipants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18 - 84 years inclusive
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
- Participant reports having a feeling of a dry mouth according to the Dry Mouth Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1). Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the Screening Visit (Visit 1).
- Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the Screening Visit (Visit 1).
Key exclusion criteria (14 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or have a positive urine pregnancy test at the Screening Visit
- Women who are breast-feeding
- Participant is currently undergoing radiotherapy and/or chemotherapy treatment
- Any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. Alzheimer's Disease
- Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotene mouthwashParticipants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds. | Other | Test Product 1 |
| Bottled mineral waterParticipants will rinse their mouth with 15 mL of the water swishing for 30 seconds. | Other | Test Product 2 |
Primary outcome
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Time frame: Within 2 minutes post product use
Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..
3 secondary outcomes
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Time frame: Within 2 minutes post product use
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Time frame: Within 30 ± 5 minutes post product use
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Time frame: Within 5 minutes post product use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biotene mouthwash and Bottled mineral water in people with Xerostomia, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 (time frame: Within 2 minutes post product use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.